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NCT05108519 Clinical Trial

Complications and Clinical Response in Cancer Patients Treated With Anti-VEGF-Related Therapies

Malignant Solid Neoplasm Clinical Trial

Official title:
A Prospective Study Evaluating Complications and Clinical Response in Cancer Patients Treated With Anti-VEGF-Related Therapies

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05108519
Other study ID # PA18-1070
Secondary ID NCI-2021-06311
Status Recruiting
Phase
First received
Last updated
Start date April 8, 2019
Est. completion date February 2, 2027

Study information
Verified date March 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study collects information about complications and clinical response in cancer patients treated with anti-VEGF-related therapies. This study aims to observe side effects that may happen to patients with advanced cancer who are treated with anti-VEGF related therapy. This may help doctors learn if there are any relationships between these side effects and how the disease may respond to treatment.

Description:

PRIMARY OBJECTIVE: I. To explore the incidence of clinical complications associated with anti-VEGF-related therapies in cancer patients treated at Emory University and the University of Texas M.D. Anderson Cancer Center (MDACC). SECONDARY OBJECTIVES: I. To explore the correlation of clinical response rates to a novel blood pressure scoring system in cancer patients treated with anti-VEGF-related therapies. II. To explore the correlation of objective response to each toxicity grade 3 or higher in cancer patients treated with anti-VEGF-related therapies. III. To investigate the validity of a novel multi-parameter-based blood pressure scoring system and to determine if the new scoring method is concordant with the current Common Terminology Criteria for Adverse Events (CTCAE) method. OUTLINE: Patients' medical records are reviewed.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date February 2, 2027
Est. primary completion date February 2, 2027
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients must be able to understand and be willing to sign a written informed consent document - Patients must be receiving any anti-VEGF-related regimen in monotherapy or combination therapy

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Electronic Health Record Review
Medical records are reviewed

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of grade 3+ adverse events (AE) at least possibly related to anti-VEGF-related treatment (overall and each type separately) For each toxicity, will estimate the odds ratio, associated 95% confidence interval and p-value. Up to 5 years
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